Comparison of a Single Versus Double Perclose Technique for TAVR
Single
The Utilization of Single Versus Double Perclose Devices for Transfemoral Aortic Valve Replacement Access Site Closure: A Prospective, Multicenter, Randomized Controlled Trial
1 other identifier
interventional
876
1 country
25
Brief Summary
Transcatheter aortic valve replacement (TAVR) has become widely recognized as a minimally invasive approach for aortic valve replacement in patients with severe aortic stenosis. It has been proven to be a safe and effective option for patients who are at low, intermediate, and prohibitive risk for surgical valve replacement. One of the critical components of procedural success in a transfemoral approach is access site management, as vascular complications strongly correlate with adverse outcomes. When major vascular complications occur, there are higher rates of major bleeding, transfusions, and renal failure requiring dialysis, as well as a significantly higher rate of 30-day and 1-year mortality. In recent years, a "preclosure" technique has emerged as a common vascular closure approach using a Perclose Proglide system (Abbott Vascular), in which sutures are deployed before dilating the arterial access site. This allows for arterial closure after dilation to sizing up to larger bore access sheaths that accommodate valve delivery systems. The sutures are subsequently harvested and tightened to close the large bore arteriotomy site at the end of the case. It has been demonstrated that the use of two Perclose devices, or double Perclose closure, is an effective closure technique with a low rate of vascular complications. A large number of TAVR centers have adopted this method for large-bore vascular closure. In the past, there have been few investigations comparing the utilization of a single Perclose device compared to a double Perclose technique. There are numerous theoretical advantages to the use of a single device, which include decreased procedural cost and procedural time. The investigation aimed to determine if there are clinical benefits as well using the single Perclose approach.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2023
Typical duration for not_applicable
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 20, 2023
CompletedFirst Submitted
Initial submission to the registry
October 30, 2023
CompletedFirst Posted
Study publicly available on registry
December 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
June 28, 2026
ExpectedOctober 14, 2025
October 1, 2025
2.5 years
October 30, 2023
October 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary end point of the trial was the rate of access site or access-related major and minor vascular complications defined according to the Valve Academic Research Consortium-3 criteria
1. Aortic dissection or aortic rupture 2. Vascular (arterial or venous) injury (perforation, rupture, dissection, stenosis, ischaemia, arterial or venous thrombosis including pulmonary embolism, arteriovenous fistula, pseudoaneurysm, haematoma, retroperitoneal haematoma, infection) or compartment syndrome resulting in death, VARC type \>\_2 bleeding, limb or visceral ischaemia, or irreversible neurologic impairment; 3. Distal embolization (non-cerebral) from a vascular source resulting in death, amputation, limb or visceral ischaemia, or irreversible endorgan damage; 4. Unplanned endovascular or surgical intervention resulting in death, VARC type \>\_2 bleeding, limb or visceral ischaemia, or irreversible neurologic impairment; 5. Closure device failure c resulting in death, VARC type \>\_2 bleeding, limb or visceral ischaemia, or irreversible neurologic impairment
The end point was assessed during index hospitalization
Secondary Outcomes (9)
The rate of the primary end point at 30 days
30 days
Components of the primary end point in-hospital and at 30 days
30 days
In-hospital and 30-day major and minor vascular complications
30 days
Unplanned vascular surgery or use of endovascular stent or stent-graft or other endovascular interventions at the puncture site
30 days
in-hospital and 30-day access site- or access-related minor, major, and disabling or life- threatening bleeding; need for blood transfusion for access site or access related bleeding or vascular complications
30 days
- +4 more secondary outcomes
Study Arms (2)
Double Perclose device
ACTIVE COMPARATORDouble Perclose device ( Perclose Proglide system, Abbott Vascular) was used for large bore arteriotomy site closure during TF-TAVR procedures
Single Perclose device
EXPERIMENTALSingle Perclose device ( Perclose Proglide system, Abbott Vascular) was used for large bore arteriotomy site closure during TF-TAVR procedures
Interventions
"Preclosure" technique has emerged as a common vascular closure approach using a Perclose Proglide system (Abbott Vascular), in which sutures are deployed before dilating the arterial access site.
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
Fujian Provincial Hospital
Fuzhou, Fujian, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
The Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong, China
Yulin First People's Hospital
Yulin, Guangxi, China
Xiangya Hospital of Central South University
Changshacun, Henan, China
Fuwai Central China Cardiovascular Hospital
Zhengzhou, Henan, China
Henan Provincial Chest Hospital
Zhengzhou, Henan, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
General Hospital of Northern Theater Command, PLA
Shenyang, Liaoning, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Qingdao Municipal Hospital
Qingdao, Shandong, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang, China
Department of Cardiology, The Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310000, China
Huzhou Central Hospital
Huzhou, Zhejiang, China
Ningbo Medical Center Li Huili Hospital
Ningbo, Zhejiang, China
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Beijing Anzhen Hospital, Capital Medical University
Beijing, China
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jianan Wang, PhD
Department of Cardiology, The Second Affiliated Hospital, School of Medicine, Zhejiang University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 30, 2023
First Posted
December 15, 2023
Study Start
October 20, 2023
Primary Completion
April 30, 2026
Study Completion (Estimated)
June 28, 2026
Last Updated
October 14, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share